Breast Neoplasms Clinical Trial
— PERUSEOfficial title:
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
| Verified date | August 2020 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
| Status | Completed |
| Enrollment | 1436 |
| Est. completion date | September 20, 2019 |
| Est. primary completion date | September 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection - HER2-positive breast cancer - Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - LVEF of at least 50 percent (%) Exclusion Criteria: - Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease - Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months - Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting - Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting - History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy - Central nervous system (CNS) metastases - Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0) - History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma - Inadequate bone marrow, liver or renal function - Uncontrolled hypertension - Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection |
| Country | Name | City | State |
|---|---|---|---|
| Algeria | CPMC; Service d'Oncologie Médicale | Algiers | |
| Argentina | Centro Oncologico Riojano Integral (CORI) | La Rioja | |
| Argentina | Instituto de Oncología de Rosario | Rosario | |
| Australia | Royal Prince Alfred Hospital; Medical Oncology | Camperdown | New South Wales |
| Australia | Canberra Hospital; Medical Oncology | Canberra | Australian Capital Territory |
| Australia | HOCA Chermside | Chermside | Queensland |
| Australia | Austin and Repatriation Medical Centre; Cancer Services | Melbourne | Victoria |
| Australia | Royal Melbourne Hospital; Hematology and Medical Oncology | Parkville | Victoria |
| Australia | Mater Hospital; Cancer Services | South Brisbane | Queensland |
| Austria | Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie | Graz | |
| Austria | LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie | Graz | |
| Austria | Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie | Innsbruck | |
| Austria | Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1 | Linz | |
| Austria | Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | |
| Austria | A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie | Steyr | |
| Austria | Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie | Wien | |
| Austria | Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie | Wien | |
| Belgium | UZ Brussel | Brussel | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | UZ Gent | Gent | |
| Belgium | UZ Leuven Gasthuisberg | Leuven | |
| Belgium | CHU Sart-Tilman | Liège | |
| Brazil | Hospital Amaral Carvalho | Jau | SP |
| Brazil | Hospital Sao Lucas - PUCRS | Porto Alegre | RS |
| Brazil | Oncologistas Associados | Rio de Janeiro | RJ |
| Brazil | Hospital das Clinicas - FMUSP | Sao Paulo | SP |
| Brazil | Hospital Perola Byington | Sao Paulo | SP |
| Brazil | Hospital Sirio Libanes; Centro de Oncologia | Sao Paulo | SP |
| Brazil | Hospital Sao Jose | São Paulo | SP |
| Canada | William Osler Health System Brampton Civic Hospital | Brampton | Ontario |
| Canada | Cross Cancer Institute ; Dept of Medical Oncology | Edmonton | Alberta |
| Canada | CSSS champlain - Charles-Le Moyne | Greenfield Park | Quebec |
| Canada | Queen Elizabeth II Health Sciences Centre; Oncology | Halifax | Nova Scotia |
| Canada | Grand River Hospital | Kitchener | Ontario |
| Canada | Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec |
| Canada | McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec |
| Canada | Lions Gate Hospital | North Vancouver | British Columbia |
| Canada | Sunnybrook Odette Cancer Centre | Toronto | Ontario |
| Canada | Bcca - Vancouver Island Cancer Centre; Oncology | Victoria | British Columbia |
| China | Beijing Cancer Hospital | Beijing | |
| China | Southwest Hospital , Third Military Medical University | Chongqing | |
| China | Sun Yet-sen University Cancer Center | Guangzhou | |
| China | Heilongjiang Provincial Tumor Hospital | Harbin | |
| China | Jiangsu Cancer Hospital | Nanjing | |
| China | Fudan University Shanghai Cancer Center | Shanghai | |
| China | Tianjin Cancer Hospital | Tianjin | |
| China | First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | |
| China | The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital) | Xi'an | |
| Ecuador | Hospital Solca Portoviejo; Oncologia | Portoviejo | |
| Ecuador | Hospital Solca Quito; Oncologia | Quito | |
| Egypt | El Mokatam HIO Hospital | Cairo | |
| Egypt | Manial Specialized Hospital; Oncology | Cairo | |
| Egypt | Nci; Oncology Dept | Cairo | |
| Estonia | North Estonia Medical Centre Foundation; Oncology Center | Tallinn | |
| Estonia | Tartu University Hospital; Clinic of Hematology and Oncology | Tartu | |
| Finland | Helsinki University Central Hospital; Oncology Clinics | Helsinki | |
| Finland | Satakunta Central Hospital; Oncology | Pori | |
| Finland | Tampere University Hospital; Dept of Oncology | Tampere | |
| Finland | Turku Uni Central Hospital; Oncology Clinics | Turku | |
| France | Clinique De L Europe; Radiotherapie Chimiotherapie | Amiens | |
| France | ICO Paul Papin; Oncologie Medicale. | Angers | |
| France | Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | |
| France | Centre Hospitalier Fleyriat; Oncologie/Hematologie | Bourg En Bresse | |
| France | Centre Leonard De Vinci;Chimiotherapie | Dechy | |
| France | Centre Georges Francois Leclerc; Oncologie 3 | Dijon | |
| France | Fondation Clement Drevon; Oncology | Dijon | |
| France | Clinique Sainte Marguerite; Oncologie Medicale | Hyeres | |
| France | Polyclinique de Blois; Chimiotherapie Ambulatoire | La Chaussee St Victor | |
| France | Clinique Victor Hugo | LeMans | |
| France | Polyclinique Du Bois; Centre Bourgogne | Lille | |
| France | Clinique Chenieux; Oncology | Limoges | |
| France | Centre Leon Berard; Departement Oncologie Medicale | Lyon | |
| France | Institut Paoli Calmettes; Oncologie Medicale | Marseille | |
| France | Centre Azureen De Cancerologie; Cons externes | Mougins | |
| France | Hopital Cochin; Unite Fonctionnelle D Oncologie | Paris | |
| France | Hopital Hotel Dieu; Oncologie Medicale | Paris | |
| France | Hopital Saint Louis; Service Onco Thoracique | Paris | |
| France | Institut Curie; Oncologie Medicale | Paris | |
| France | Centre Catalan D' Oncologie | Perpignan | |
| France | Polyclinique De Courlancy; Centre Radiotherapie Oncologie | Reims | |
| France | Centre Eugene Marquis; Unite Huguenin | Rennes | |
| France | Centre Rene Huguenin; ONCOLOGIE GENETIQUE | Saint Cloud | |
| France | Chp Saint Gregoire; Cancerologie Radiotherapie | Saint Gregoire | |
| France | Ico Rene Gauducheau; Oncologie | Saint Herblain | |
| France | Institut D Oncologie Medical | Strasbourg | |
| France | Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | |
| France | Hopital Prive Drome Ardeche; Hopital De Jour | Valence | |
| France | Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie | Valenciennes | |
| Germany | Klinikum am Bruderwald; Frauenklinik | Bamberg | |
| Germany | Gynaekologicum Bremen; Prof. Dr. Willibald Schröder | Bremen | |
| Germany | Universitätsklinikum Erlangen; Frauenklinik | Erlangen | |
| Germany | Universitätsklinikum Essen; Zentrum Für Frauenheilkunde | Essen | |
| Germany | Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe | Esslingen | |
| Germany | AGAPLESION Markus-Krankenhaus | Frankfurt | |
| Germany | SRH Wald-Klinikum Gera; Klinik für Frauenheilkunde und Geburtshilfe | Gera | |
| Germany | Universitätsklinikum Hamburg-Eppendorf; Frauenklinik | Hamburg | |
| Germany | Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding | Hannover | |
| Germany | Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg | Heidelberg | |
| Germany | Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe | Homburg/Saar | |
| Germany | St.-Vincenz-Krankenhaus; Frauenklinik | Limburg | |
| Germany | Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe | Lübeck | |
| Germany | Brustzentrum Rhein-Ruhr Servicegesellschaft mbH | Mönchengladbach | |
| Germany | Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde | München | |
| Germany | Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe | Neuruppin | |
| Germany | Agaplesion Diakonieklinikum Rotenburg | Rotenburg/Wümme | |
| Germany | Praxis Dr. Wagner | Saarbruecken | |
| Germany | Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe | Torgau | |
| Germany | Universitätsklinik Tübingen; Frauenklinik | Tübingen | |
| Greece | Hippokratio Hospital; 2Nd Internal Medicine | ????a | |
| Greece | University Hospital of Larissa; Oncology | ?a??sa | |
| Greece | Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine | Athens | |
| Greece | University General Hospital of Heraklion | Crete | |
| Greece | University Hospital of Patras Medical Oncology | Patras | |
| Greece | Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | |
| Greece | Papageorgiou General Hospital; Medical Oncology | Thessaloniki | |
| Hong Kong | Queen Elizabeth Hospital; Clinical Oncology | Hong Kong | |
| Hungary | Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X | Budapest | |
| Hungary | Orszagos Onkologial Intezet; Onkologiai Osztaly X | Budapest | |
| Hungary | Szent Margit Hospital; Dept. of Oncology | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Kozpont ; Department of Oncology | Debrecen | |
| Hungary | Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly | Miskolc | |
| Hungary | Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | |
| Israel | Soroka Medical Center; Oncology Dept | Beer Sheva | |
| Israel | Rambam Medical Center; Oncology | Haifa | |
| Israel | Wolfson Hospital; Oncology | Holon | |
| Israel | Hadassah Ein Karem Hospital; Oncology Dept | Jerusalem | |
| Israel | Shaare Zedek Medical Center; Oncology Dept | Jerusalem | |
| Israel | Nahariya Hospital; Oncology | Nahariya | |
| Israel | Rabin Medical Center; Oncology Dept | Petach Tikva | |
| Israel | Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | |
| Israel | Kaplan Medical Center; Oncology Inst. | Rehovot | |
| Israel | Assuta Medical Centre; Oncology | Tel Aviv | |
| Israel | Sourasky / Ichilov Hospital; Dept. of Oncology | Tel Aviv | |
| Israel | Assaf Harofeh; Oncology | Zerifin | |
| Italy | Ospedali Riuniti Di Ancona; Oncology | Ancona | Marche |
| Italy | Azienda Ospedaliera San Giuseppe Moscati | Avellino | Campania |
| Italy | Asst Papa Giovanni XXIII; Oncologia Medica | Bergamo | Lombardia |
| Italy | Arcispedale S.Anna; Oncologia Medica | Cona (Ferrara) | Veneto |
| Italy | Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1 | Firenze | Toscana |
| Italy | Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica | Genova | Liguria |
| Italy | Ospedale Mater Salutis; Dept of Oncology | Legnago | Lombardia |
| Italy | Ospedale Di Macerata; Oncologia | Macerata | Marche |
| Italy | Irccs Ospedale San Raffaele;Oncologia Medica | Milano | Lombardia |
| Italy | Istituto Europeo Di Oncologia | Milano | Lombardia |
| Italy | Ospedale Maggiore Della Carita; Oncologia Medica | Novara | Piemonte |
| Italy | Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent. | Pavia | Lombardia |
| Italy | Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia | Piacenza | Emilia-Romagna |
| Italy | Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica | Ponderano (BI) | Piemonte |
| Italy | Azienda USL di Ravenna; Unità Operativa di Oncologia Medica | Ravenna | Emilia-Romagna |
| Italy | Ospedale S. Vincenzo; Oncologia Medica | Taormina | Sicilia |
| Italy | Fondazione Del Piemonte; Medical Oncology | Torino | Piemonte |
| Italy | Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia | Udine | Friuli-Venezia Giulia |
| Italy | Ospedale Belcolle Di Viterbo; Oncologia | Viterbo | Lazio |
| Lebanon | American University of Beirut - Medical Center | Beirut | |
| Lebanon | Hotel Dieu de France; Oncology | Beirut | |
| Lithuania | Hospital of Lithuanian University of Health. Sciences Kaunas Clinics | Kaunas | |
| Lithuania | Uni Oncology Inst. ; Chemo - Radiation Dept | Vilnius | |
| Mexico | Iem-Fucam | D.f. | |
| Mexico | Medica Sur Centro Oncologico Integral | D.f. | |
| Mexico | Instituto Nacional de Cancerologia; Oncology | Distrito Federal | |
| Mexico | Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia | Mexico City | |
| Mexico | Consultorio de Medicina Especializada; Dentro de Condominio San Francisco | Mexico City | |
| Mexico | Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán | Mexico City | |
| Mexico | Hospital General de México; Unidad de Oncologia | Mexico DF | |
| Mexico | Cancerologia de Queretaro; Oncologia | Queretaro, Queretaro | |
| Morocco | Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie | Rabat | |
| Netherlands | Medisch Centrum Alkmaar | Alkmaar | |
| Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | |
| Netherlands | Catharina ZKHS; Inwendige Geneeskunde Afd. | Eindhoven | |
| Netherlands | Martini Ziekenhuis; Dept of Internal Medicine | Groningen | |
| Netherlands | Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde | Leidschendam | |
| Netherlands | Ikazia Ziekenhuis; Interne Oncologie | Rotterdam | |
| Netherlands | Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde | Tilburg | |
| Netherlands | Vie Curie | Venlo | |
| Pakistan | Shifa International Hospital; Department of Oncology | Islamabad | |
| Pakistan | Hameed Latif Hospital; Department of Oncology | Lahore | |
| Pakistan | Shaukat Khanum Memorial Cancer Hospital; Department of Oncology | Lahore | |
| Peru | Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional | Lima | |
| Peru | Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología | Lima | |
| Peru | Instituto;Oncologico Miraflores | Lima | |
| Poland | Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | Bialystok | |
| Poland | Swietokrzyskie Centrum Onkologii; Dzial Chemioterapii | Kielce | |
| Poland | Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Onkologii | Kraków | |
| Poland | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii | Lodz | |
| Poland | Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | |
| Poland | Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon | Warszawa | |
| Portugal | IPO de Coimbra; Servico de Oncologia Medica | Coimbra | |
| Portugal | Hospital do Espirito Santo; Servico de Oncologia Medica | Evora | |
| Portugal | Centro Clinico Champalimaud; Oncologia Medica | Lisboa | |
| Portugal | Hospital da Luz; Departamento de Oncologia Medica | Lisboa | |
| Portugal | Hospital de Santa Maria; Servico de Oncologia Medica | Lisboa | |
| Portugal | Hospital Beatriz Angelo; Departamento de Oncologia | Loures | |
| Portugal | Hospital de Sao Joao; Servico de Oncologia | Porto | |
| Portugal | IPO do Porto; Servico de Oncologia Medica | Porto | |
| Saudi Arabia | King Abdul Aziz Medical City, King Fahd National Guard; Oncology | Riyadh | |
| Saudi Arabia | King Faisal Specialist Hospital & Research Centre; Oncology | Riyadh | |
| Serbia | Institute for Onc/Rad Serbia | Belgrade | |
| Serbia | Oncology Institute of Vojvodina | Sremska Kamenica | |
| Slovenia | Institute of Oncology Ljubljana | Ljubljana | |
| Spain | Fundacion Hospital de Alcorcon; Servicio de Oncologia | Alcorcon | Madrid |
| Spain | Hospital Virgen de los Lirios; Servicio de Oncologia | Alcoy | Alicante |
| Spain | Hospital de Barbastro; Servicio de Oncologia | Barbastro | Huesca |
| Spain | Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | |
| Spain | Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | |
| Spain | Hospital Quiron Barcelona; Servicio de Oncologia | Barcelona | |
| Spain | Hospital de Basurto; Servicio de Oncologia | Bilbao | Vizcaya |
| Spain | Complejo Asistencial Universitario De Burgos; Servicio de Oncologia | Burgos | |
| Spain | Hospital San Pedro De Alcantara; Servicio de Oncologia | Caceres | |
| Spain | Hospital Provincial de Castellon; Servicio de Oncologia | Castellon de La Plana | Castellon |
| Spain | Hospital General de Elda; Servicio de Oncologia | Elda | Alicante |
| Spain | Hospital de Cabueñes; Servicio de Oncologia | Gijon | Asturias |
| Spain | Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia | Girona | |
| Spain | Hospital Universitario Virgen de las Nieves; Servicio de Oncologia | Granada | |
| Spain | Hospital General Universitario de Guadalajara; Servicio de Oncologia | Guadalajara | |
| Spain | Hospital de Jerez de la Frontera; Servicio de Oncologia | Jerez de La Frontera | Cadiz |
| Spain | Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia | Las Palmas de Gran Canaria | LAS Palmas |
| Spain | Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia | Las Palmas de Gran Canaria | LAS Palmas |
| Spain | Hospital Severo Ochoa; Servicio de Oncologia | Leganes | Madrid |
| Spain | Complejo Asistencial Universitario de Leon; Servicio de Oncologia | Leon | |
| Spain | Complejo Hospitalario San Millan - San Pedro; Servicio de Oncologia | Logroño | LA Rioja |
| Spain | Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | |
| Spain | Fundacion Jimenez Diaz; Servicio de Oncologia | Madrid | |
| Spain | HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | |
| Spain | Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | |
| Spain | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | |
| Spain | Hospital Universitario Clínico San Carlos; Servicio de Oncologia | Madrid | |
| Spain | Hospital Universitario La Paz; Servicio de Oncologia | Madrid | |
| Spain | Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Malaga | |
| Spain | Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia | Murcia | |
| Spain | Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | |
| Spain | Hospital de Navarra; Servicio de Oncologia | Navarra | |
| Spain | Complejo Hospitalario de Orense; Servicio de Oncologia | Orense | |
| Spain | Hospital Universitario Son Espases | Palma De Mallorca | Islas Baleares |
| Spain | Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarra |
| Spain | Hospital Universitari Sant Joan de Reus; Servicio de Oncologia | Reus | Tarragona |
| Spain | Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona |
| Spain | Hospital de Sagunto; Servicio de Oncologia | Sagunto | Valencia |
| Spain | Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Salamanca | |
| Spain | Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia | Santa Cruz de Tenerife | Tenerife |
| Spain | Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña |
| Spain | Hospital Universitario Virgen Macarena; Servicio de Oncologia | Sevilla | |
| Spain | Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia | Valencia | |
| Spain | Hospital Universitario Dr. Peset | Valencia | |
| Spain | Hospital Clinico Universitario de Valladolid; Servicio de Oncologia | Valladolid | |
| Spain | Hospital de Rio Hortega; Servicio de Oncologia | Valladolid | |
| Spain | Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia | Zaragoza | |
| Spain | Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | |
| Sweden | Gävle Sjukhus; Onkologiska Kliniken | Gävle | |
| Sweden | Sahlgrenska Universitetssjukhuset; Jubileumskliniken | Göteborg | |
| Sweden | Centralsjukhuset Karlstad, Onkologkliniken | Karlstad | |
| Sweden | Skånes University Hospital, Skånes Department of Onclology | Lund | |
| Sweden | Västmanlands sjukhus Västerås, Onkologkliniken | Västerås | |
| Sweden | Centrallasarettet Växjö, Onkologkliniken | Vaxjo | |
| Turkey | Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology | Adana | |
| Turkey | Akdeniz University Medical Faculty; Medical Oncology Department | Antalya | |
| Turkey | Ege University Medical Faculty; Medical Oncology Department | Bornova, I?zmi?r | |
| Turkey | Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Edirne | |
| Turkey | Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sihhiye/Ankara | |
| Ukraine | Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology | Dnipropetrovsk | |
| Ukraine | Kyiv City Clinical Oncological Center; Chemotherapy Department | Kiev | |
| Ukraine | State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department | Lviv | |
| Ukraine | Zaporozhye Regional Oncology Hospital; Dept of Oncology | Zaporozhye | |
| United Arab Emirates | Tawam Hospital | Al Ain | |
| United Kingdom | Royal United Hospital; Oncology Department | Bath | |
| United Kingdom | City Hospital NHS Trust | Birmingham | |
| United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
| United Kingdom | Addenbrookes Hospital; Dept of Oncology | Cambridge | |
| United Kingdom | Velindre Hospital | Cardiff | |
| United Kingdom | Walsgrave Hospital | Coventry | |
| United Kingdom | Royal Derby Hospital | Derby | |
| United Kingdom | University Hospital of North Durham | Durham | |
| United Kingdom | Hairmyres Hospital; Oncology Dept | East Kilbride | |
| United Kingdom | Eastbourne District Hospital; Department of Pharmacy | Eastbourne | |
| United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | |
| United Kingdom | Diana Princess of Wales Hosp. | Grimsby | |
| United Kingdom | Royal Surrey County Hospital | Guildford | |
| United Kingdom | Leeds Teaching Hosp NHS Trust;St James's Institute of Onc | Leeds | |
| United Kingdom | Huddersfield Royal Infirmary - Pharmacy department | Lindley | |
| United Kingdom | Barts and the London NHS Trust. | London | |
| United Kingdom | Kings College Hospital NHS Foundation Trust | London | |
| United Kingdom | Royal Free Hospital; Dept of Oncology | London | |
| United Kingdom | Royal Marsden Hospital - London | London | |
| United Kingdom | Macclesfield District General Hospital | Macclesfield | |
| United Kingdom | Christie Hospital; Breast Cancer Research Office | Manchester | |
| United Kingdom | James Cook Uni Hospital | Middlesborough | |
| United Kingdom | Freeman Hospital; Northern Centre For Cancer Care | New Castle Upon Tyne | |
| United Kingdom | Mount Vernon Cancer Centre | Northwood | |
| United Kingdom | Churchill Hospital | Oxford | |
| United Kingdom | Peterborough City Hospital | Peterborough | |
| United Kingdom | Derriford Hospital; Plymouth Oncology Centre | Plymouth | |
| United Kingdom | Musgrove Park Hospital | Somerset | |
| United Kingdom | The Royal Marsden Hospital | Sutton | |
| United Kingdom | Royal Cornwall Hospital | Truro | |
| United Kingdom | Wishaw General Hospital | Wishaw | |
| Uruguay | Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología | Montevideo | |
| Uruguay | Hospital Central De Las FF.AA.; Servicio De Oncologia | Montevideo | |
| Uruguay | Hospital Pereira Rossell; Oncology Department | Montevideo | |
| Venezuela | Centro Integral de Oncología | Caracas | |
| Venezuela | Centro Médico Docente La Trinidad; Servicio de Gastroenterología | Caracas |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Lebanon, Lithuania, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal | The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Primary | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal | The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Primary | Number of Participants With Grade =3 Treatment-Emergent Adverse Events, Occurring in =1% of Participants by System Organ Class and Preferred Term | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =10% of Participants by System Organ Class | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Grade =3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.5% of Participants by Preferred Term | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.2% of Participants by Preferred Term | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.5% of Participants by Preferred Term | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in =5% of Participants by Category | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Grade =3 Treatment-Emergent Adverse Events to Monitor, Occurring in =0.5% of Participants by Category and Preferred Term | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by Age (=65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade =3 TEAEs, Any-Grade and Grade =3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade =3 TEAEs, Any-Grade and Grade =3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With a Congestive Heart Failure Event | Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1). | From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Time to Onset of the First Episode of Congestive Heart Failure | Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included. | From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | All participants must have had a baseline LVEF =50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value. | Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | All participants must have had a baseline LVEF greater than or equal to (=)50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (<)10% points or no change in LVEF; 2) an absolute LVEF value <45% points and a decrease from baseline LVEF =10% points to <15% points; 3) an absolute LVEF value <45% points and a decrease from baseline LVEF =15% points; or 4) an absolute LVEF value =45% points and a decrease from baseline LVEF =10% points. BL = baseline; Decr. = decrease; Incr. = increase | Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Primary | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Secondary | Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Age (=65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Region of Enrollment: Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Age (=65 vs. >65 Years): Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Taxane Chemotherapy: Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Visceral Disease at Baseline: Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (=4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders. | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 | Best overall response (BOR) was defined as the best response recorded from the first dose of study treatment until disease progression/recurrence or death in the absence of disease progression. The hierarchy used to determine BOR: Complete Response (CR)>Partial Response (PR)>Stable Disease (SD)>Progressive Disease (PD)>Not Evaluable. Note that CR or PR was confirmed =4 weeks later. RECIST v1.1 responses are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.; PD = At least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study, and absolute increase of =5 mm.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Age (=65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (=4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders. | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (=4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders. | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Clinical Benefit Rate (CR or PR, or SD for at Least 6 Months) Based on Best Overall Response as Assessed by the Investigator Using RECIST v.1.1 | The clinical benefit rate was defined as the percentage of participants whose best confirmed response (=4 weeks later) was a complete response (CR) or partial response (PR), or stable disease (SD) that lasted at least 6 months, as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Clinical benefit responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least 20% increase in sum of diameters of target lesions and absolute increase of =5 mm), taking as reference the smallest sum diameters while on study. | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Duration of Response as Assessed by the Investigator Using RECIST v1.1 | Duration of response (DOR) was defined as the time from when a confirmed best overall response of complete response (CR) or partial response (PR) was first documented to first documented disease progression or death from any cause (whichever occurred first). DOR was analyzed using a Kaplan-Meier approach. Participants who had not progressed or died after having had a confirmed response were censored at the date of their last tumor measurement. Response was assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From date of first confirmed response (CR or PR) to first documented disease progression or death from any cause, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Time to Response for Participants With Best Overall Response of Complete Response or Partial Response, as Assessed by the Investigator Using RECIST v1.1 | Time to response (TTR) was defined as the time from the first study treatment administration to the date of first confirmed response (CR or PR). TTR was analyzed using a Kaplan-Meier approach. Participants who did not have CR or PR were censored at the date of their last evaluable tumor assessment. Participants for whom no post-baseline tumor assessments were available were censored at Day 1. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From date of first study treatment until date of first confirmed response (CR or PR). The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | |
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. Participants were given a series of statements in each subscale and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B total score, ranging from 0 to 148, was the sum of the scores for each subscale, provided that at least 80% of the items had been answered; a higher score indicated a better quality of life. If any of the 5 subscale scores were missing, the total score was also set to missing. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Secondary | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the physical well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B physical well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Secondary | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the social well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B social well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Secondary | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the emotional well-being subscale, participants were given a series of 6 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B emotional well-being subscale score, ranging from 0 to 24, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Secondary | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the functional well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B functional well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | |
| Secondary | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the breast cancer subscale, participants were given a series of 10 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B breast cancer subscale score, ranging from 0 to 40, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. |
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